Tagged with regulatory,

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from 50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your…

China Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons behind these rejections, and suggests how applicants can avoid them in future.   In 2021, China’s Center for Disease Evaluation…

Spain What major regulatory trends are emerging in Europe and in Spain? As one of the founding partners of a law firm focused uniquely on the life sciences industry, Faus & Moliner Abogados, Jordi Faus has been confronting the industry’s unique legal issues for over 25 years. In a recent PharmaBoardroom…

Vietnam Despite a decline in pharmaceutical sales during the COVID-19 pandemic, Vietnam is among the 17 countries with the most rapidly growing pharmaceutical industries in the world, as reported by nganhduoc.vn in its 2022 pharma industry forecast. With a market value of some USD 10 billion in 2020, according to another…

Egypt The head of the Pharmaceutical Chamber of the Federation of Egyptian Industries, Gamal El-Leithy, shares his view on the positive developments driving the growth of Egypt’s pharma market, including the creation of an independent regulatory body and a procurement agency. In addition, he analyses the country’s response to the COVID-19…

Global Sarah Pope Miksinski, executive director/CMS regulatory affairs, and Gregory Rullo, senior director regulatory affairs, at AstraZeneca discuss the need for common ground among regulators and industry when it comes to patient centricity and for strategic leadership to address differing regulatory control-strategy requirements. In today’s increasingly complex and intricate pharmaceutical landscape,…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

China The following is an overview from Accestra Consulting* of Part 2 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including an overview of administrative drug approvals and fast track review pathways by CDE.   Abstract Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of…

China Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent legislation to improve China’s drug regulatory capacity and why it potentially marks a new era for the country’s innovative pharma industry.   On April 27, 2021, the General Office of…

Turkey Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of…